• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 01/28/2019
Event Type  Injury  
Manufacturer Narrative

The device was returned to olympus and evaluation is pending and microbial testing. The scope will be sent to an independent laboratory for microbial testing. As part of our investigation, on (b)(4) 2019 an olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the facility¿s reprocessing practices and provide training if necessary. Upon arrival the ess was informed that the facility did not have a leak tester and wanted the in-service/observation to be rescheduled for a later date. To date the user facility has not finalized date for this visit. If additional information received this report will be supplemented accordingly.

 
Event Description

Olympus was informed that two patients developed klebsiella pneumonia infections after undergoing cystoscopy procedures using two of the facility¿s cystonephrofiberscopes (sn. (b)(4), sn. (b)(4)). The patients were treated with intravenous antibiotics. In addition, the user facility reported that they use enzyme and aldahol cleaner to disinfect and clean the scope. The minimum effective concentration is being checked every 2 weeks. The endoscope channel is being brushed during manual cleaning using a reusable brush (model: unk). The scope is precleaned immediately after the procedure as it is rinsed, flushed, soaped and the steps are then repeated. The scope is not being leaked tested prior to manual cleaning. Air is flushed into the scope after reprocessing. There is no known issue with the facility¿s automatic endoscope reprocessor (aer) (model: unk). The facility's last in-service with an olympus endoscopy support specialist was conducted on (b)(4) 2019. There have been no changes to the facility¿s reprocessing staff since the last in-service. The user facility reported that all the reprocessing staffs were trained on how to properly reprocess an endoscope. This is 1 of 2 reports.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTONEPHROFIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8364743
MDR Text Key136986410
Report Number2951238-2019-00453
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/24/2019 Patient Sequence Number: 1
-
-